3MATIC

K060950 · Materialise NV · LLZ · May 18, 2006 · Radiology

Device Facts

• Record ID: K060950
• Device Name: 3MATIC
• Applicant: Materialise NV
• Product Code: LLZ · Radiology
• Decision Date: May 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Materialise's 3Matic is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient specific medical and dental/orthodontic accessories and dental restorations.

Device Story

3Matic is software for computer-assisted design (CAD) and manufacturing (CAM) of medical/dental prostheses and patient-specific accessories. It processes medical imaging data to facilitate the design of exo- and endo-prostheses, dental restorations, and orthodontic appliances. Used by clinicians or technicians in a clinical or laboratory setting, the software enables the creation of custom-fit devices based on patient anatomy. The output is a digital design file used for manufacturing, which assists healthcare providers in planning and producing patient-specific medical devices, potentially improving fit and clinical outcomes for patients requiring custom prosthetics or restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software for CAD/CAM of medical/dental prostheses. Functions as a Picture Archiving and Communications System (PACS) accessory (21 CFR 892.2050). Non-sterile. Operates as a standalone software application for digital design and manufacturing workflows.

Indications for Use

Indicated for use as software for computer-assisted design and manufacturing of medical exo- and endo-prostheses, patient-specific medical and dental/orthodontic accessories, and dental restorations.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• SimPlant System (K033849)
• Etkon ES-1

Submission Summary (Full Text)

{0}------------------------------------------------

KD 60950

## AY 1 8 2006

#### SUMMARY OF SAFETY AND EFFECTIVENESS MATERIALISE SIMPLANT SYSTEM

#### Proprietary Name:

3Matic

#### COMMON NAME:

Software for computer assisted design and manufacturing of medical and dental prostheses

#### Classification Name:

Picture Archiving and Communications System

DEVICE CLASSIFICATION:

21 CFR 892.2050.

REGULATORY CLASS:

Class II

Classification Product Code:

LLZ

SUBSEQUENT PRODUCT CODES:

NOF

SUBMITTER'S NAME AND ADDRESS:

MATERIALISE N. V. Technologielaan 15 B-3001 LEUVEN, BELGIUM

ESTABLISHMENT REGISTRATION NO:

3003998208

Contact Person: Carl Van Lierde, Materialise N.V.

Quality Manager

Summary Preparation Date: March 21, 2006

#### Predicate Device

3Matic is claimed to be substantially equivalent in material, design, and function to the SimPlant System, which was cleared by FDA under 510(k) K033849 on May 25, 2004.

3Matic is claimed to be substantially equivalent in material, design, and function to the Etkon ES-1 product from Etkon, which was listed with FDA on January 4, 2005.

{1}------------------------------------------------

#### Indications for Use

Materialise's 3Matic is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient specific medical and dental/orthodontic accessories and dental restorations.

### STERILIZATION

The 3Matic is provided non-sterile.

### SUBSTANTIAL EQUIVALENCE

The 3Matic is considered to be substantially equivalent to the SimPlant System and Etkon ES-1.

#### CONCLUSION

The 3Matic is considered to be substantially equivalent in design, material and function to the SimPlant System and Etkon ES-1.

{2}------------------------------------------------

Food and Drug Administration. 9200 Corporate Blvd. Rockville MD 20850

MAY 1 8 2006

Mr. Carl Van Lierde Quality Manager Materialise NV Medical Division Technologielaan 12, Leuven 3001 BELGIUM

Re: K060950

Trade/Device Name: 3Matic Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 27, 2006 Received: April 6, 2006

Dear Mr. Van Lierde:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

Protecting and Promoting Public Health

{3}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# K 06 0950

# Indications for Use

510(k) Number (if known):

Device Name: 3Matic

Indications For Use:

Materialise's 3Matic is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient specific medical and dental/orthodontic accessories and dental restorations.

Prescription Use (Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David a. Lyomm

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________